Dynarex 三通旋塞
K号: K172266 · 2018-03-14
广告
决定日期2018-03-14
产品代码FMG
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
Dynarex Three-Way Stopcock is the device name listed in this FDA 510(k) record. The listed applicant is Dynarex Corporation. It received FDA 510(k) clearance on 2018-03-14 under 510(k) number K172266. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Dynarex Three-Way Stopcock?
Dynarex Three-Way Stopcock is a medical device that received FDA 510(k) clearance on 2018-03-14. The listed applicant is Dynarex Corporation. The 510(k) number is K172266.
When did Dynarex Three-Way Stopcock receive FDA 510(k) clearance?
Dynarex Three-Way Stopcock received FDA 510(k) clearance on 2018-03-14, under 510(k) number K172266.
Who is the listed applicant for Dynarex Three-Way Stopcock?
The FDA 510(k) record lists Dynarex Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dynarex Three-Way Stopcock?
The FDA product code for Dynarex Three-Way Stopcock is FMG.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Dynarex Corporation为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：FMG）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K242255Qitexio® 4路旋塞（QIT014）MedexK223499三通截止阀M/S Romsons InternationalK223175腔内给药套装，带旋塞和歧管Baxter Healthcare CorporationK211204SafePort™ 多路阀（或旋塞）Elcam Medical AcalK210516Clicky 十字Yomura Technologies, Inc.K190539TurnSignal 止血夹无菌，TurnSignal 止血夹非无菌，TurnSignal 配有歧管的止血夹无菌，TurnSignal 配有歧管的止血夹非无菌Monumedical, LLC
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告